Claims for Patent: 7,893,045

Summary for Patent: 7,893,045

Title:	Methods for treating lymphomas in certain patient populations and screening patients for said therapy
Abstract:	Methods for predicting a response of a patient having a lymphoma to a therapy regimen of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione using prognostic factors of a patient\'s disease burden, absolute lymphocyte count or time since last rituximab therapy are disclosed. Specific methods of treating a lymphoma encompass the administration of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione to a patient who has one or more of the favorable profiles, alone or in combination with immunosuppressive agents such as rituximab.
Inventor(s):	Pietronigro; Dennis (Clinton, NJ), Ervin-Hayes; Annette (Watchung, NJ), Zeldis; Jerome B. (Princeton, NJ)
Assignee:	Celgene Corporation (Summit, NJ)
Application Number:	12/221,651
Patent Claims:	1. A method for treating a lymphoma in a human, comprising: a) measuring a patient's disease burden, an absolute lymphocyte count or time since last rituximab therapy; b) selecting a patient who has a disease burden of less than 50 cm.sup.2, an absolute lymphocyte count greater than 0.6.times.10.sup.9/L, or not less than 230 days since last rituximab therapy; and c) administering a therapeutically effective amount of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione to the patient. 2. The method of claim 1, wherein the patient has two or more of the following: a disease burden of less than 50 cm.sup.2, an absolute lymphocyte count greater than 0.6.times.10.sup.9/L, or not less than 230 days since last rituximab therapy. 3. The method of claim 1, wherein the patient has all of the following: a disease burden of less than 50 cm.sup.2, an absolute lymphocyte count greater than 0.6.times.10.sup.9/L, and not less than 230 days since last rituximab therapy. 4. The method of claim 1, wherein the patient is refractory to rituximab. 5. The method of claim 1, wherein the patient has not been treated with rituximab. 6. The method of claim 1, wherein the lymphoma is relapsed, refractory or resistant to conventional therapy. 7. The method of claim 1, wherein the lymphoma is non-Hodgkin's lymphoma. 8. The method of claim 1, wherein the lymphoma is mantle cell lymphoma, follicular center lymphoma, diffuse large B-cell lymphoma, transformed lymphoma, lymphocytic lymphoma of intermediate differentiation, intermediate lymphocytic lymphoma, diffuse poorly differentiated lymphocytic lymphoma, centrocytic lymphoma, diffuse small-cleaved cell lymphoma, peripheral T-cell lymphoma, cutaneous T-cell lymphoma, cutaneous B-cell lymphoma, or mantle zone lymphoma. 9. The method of claim 1, wherein the amount of 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione administered is about 10, 15, 20 or 25 mg per day. 10. The method of claim 1, wherein the amount of 3-(4-amino-oxo-1 ,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione administered is about 25 mg per day. 11. The method of claim 1, wherein 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione administered is enantiomerically pure. 12. The method of claim 11, wherein 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione administered is S enantiomer. 13. The method of claim 11, wherein 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione administered is R enantiomer. 14. The method of claim 1, wherein 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione is administered orally. 15. The method of claim 14, wherein 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione is administered in the form of a capsule. 16. The method of claim 15, wherein 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione is administered in the form of a capsule of 5 mg, 10 mg, 15 mg or 25 mg. 17. The method of claim 1, wherein 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione is administered for 21 days followed by seven days rest in a 28 day cycle. 18. The method of claim 17 wherein 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione is administered in an amount of about 25 mg per day for 21 days followed by seven days rest in a 28 day cycle. 19. The method of claim 18, further comprising administration of the compound for 52 weeks as tolerated or until disease progression. 20. The method of claim 19, further comprising administering the compound to a patient who achieves a complete response for two additional cycles. 21. The method of claim 1, further comprising administering a therapeutically effective amount of a second active agent. 22. The method of claim 21, wherein the second active agent is an antibody, a hematopoietic growth factor, a cytokine, an anti-cancer agent, an antibiotic, a cox-2 inhibitor, an immunomodulatory agent, an immunosuppressive agent, or a corticosteroid. 23. The method of claim 1, wherein 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione is administered before administering rituximab. 24. The method of claim 1, wherein 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione is administered before administering immune suppressive agents. 25. The method of claim 1, wherein the disease burden is estimated by no single tumor with diameter greater than 4.5 cm.

Details for Patent 7,893,045

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2027-08-07
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2027-08-07
Genentech, Inc.	RITUXAN HYCELA	rituximab and hyaluronidase human	Injection	761064	06/22/2017		2027-08-07